510(k) · Cleared

Recalled · Class II · 2013

Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode

K970066510(k) TraditionalCleared Feb 18, 199741-day reviewClass II21 CFR 878.4400Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unimed Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 18, 1997 as substantially equivalent to K962935 (Unimed Surgical Products, Inc., 1996) and 2 other predicates after a 41-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it. It has been recalled once.

Decided: Feb 18, 1997
Review: 41 days
Class: Class II
Product code: GEI
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K945030 (1994). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK945030 Surgi-Link Laparoscopic ElectrodesUnimed Surgical Products, Inc. · 1994
This deviceK970066 Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation ElectrodeUnimed Surgical Products, Inc. · 1997
Descendant · cites it directly · 1 of its ownK020579 Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and…Aaron Medical Industries · 2002
Descendant · 2 generations on · 0 of its ownK170703 Single Use Arthroscopic Electrode (with Pencil)Modern Medical Equipment Manufacturing Limited · 2018
Descendant · cites it directly · 0 of its ownK132224 Unimed Surgical Coated Electrosurgical ElectrodesUnimed Surgical Products, Inc. · 2013

Most influential descendants

Showing 3 of 3 · See all

K020579Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03Aaron Medical Industries · 2002 · cites it directly1descendant
K170703Single Use Arthroscopic Electrode (with Pencil)Modern Medical Equipment Manufacturing Limited · 2018 · 2 generations on0descendants
K132224Unimed Surgical Coated Electrosurgical ElectrodesUnimed Surgical Products, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945030	Surgi-Link Laparoscopic Electrodes	Unimed Surgical Products, Inc.	1994	—
0 (this device)	K970066	Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode	Unimed Surgical Products, Inc.	1997	—
+1	K020579	Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03	Aaron Medical Industries	2002	—
+2	K170703	Single Use Arthroscopic Electrode (with Pencil)	Modern Medical Equipment Manufacturing Limited	2018	—
+1	K132224	Unimed Surgical Coated Electrosurgical Electrodes	Unimed Surgical Products, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2013	1	0
2018	1	0

FIG. 1 — Lineage of K970066, 1994–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K962935	Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode Summary page 1 …e, single use only. SUBSTANTIAL EQUIVALENCE: This 510(k) notification represents the adding of a coating that is identical to the coatings on unimed’s Coated Electrode (K962935) to unimed Electrodes identified as unimed Laparoscopic Electrodes (K945030) and unimed Suction-Irrigation Electrodes (K963338).…	Unimed Surgical Products, Inc.	1996	13
*	K945030	Surgi-Link Laparoscopic Electrodes Summary page 1 …ents the adding of a coating that is identical to the coatings on unimed’s Coated Electrode (K962935) to unimed Electrodes identified as unimed Laparoscopic Electrodes (K945030) and unimed Suction-Irrigation Electrodes (K963338). -28-	Unimed Surgical Products, Inc.	1994	—
*	K963338	Unimed Suction-Irrigation Electrode and Sliding Sheath Summary page 1 …the coatings on unimed’s Coated Electrode (K962935) to unimed Electrodes identified as unimed Laparoscopic Electrodes (K945030) and unimed Suction-Irrigation Electrodes (K963338). -28-	Unimed Surgical Products, Inc.	1996	—

Also cleared against K962935: 2 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020579	Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03	Aaron Medical Industries	2002	1
K132224	Unimed Surgical Coated Electrosurgical Electrodes	Unimed Surgical Products, Inc.	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 15, 2013	Class II	Z-1347-2013	No Marketing Application	Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K020579 (Aaron Medical Industries, 2002) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K962935.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

https://510kreport.com/device/K970066 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970066: Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970066

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026